SOLICITATION NOTICE
B -- Predictive Blood and Cerebrospinal Fluid Metabolomic Markers in Alzheimer’s Disease - Statement of Work
- Notice Date
- 4/2/2015
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-PSOL-15-188
- Archive Date
- 5/1/2015
- Point of Contact
- Samantha A. Kelly, Phone: 3014028855
- E-Mail Address
-
samantha.kelly2@nih.gov
(samantha.kelly2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work (SOW) INTRODUCTION: THIS IS A PRE-SOLICIATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPOSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute of Aging (NIA) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to BIOCRATES Life Sciences AG, Eduard-Bodem-Gasse 8, A-6020 Innsbruck, Austria DN220414p Landesgericht Innsbruck for a service project that will use a method called quantitative targeted metabolomics for measuring the absolute concentrations of 180 metabolites in serum and post-mortem brain samples to discover predictive blood biomarkers of Alzheimer's Disease (AD) and markers of resilience to AD pathology. NORTH AERMICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS code 541711 with a Size Standard of 500 employees. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-80, dated March 2, 2015. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-contracting by Negotiations at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY: This acquisition is conducted under the authority of 41 U.S.C 3304(a)(1) under provisions of the statutory authority of FAR Subpart 6.302-1(a)(2)(i)(A)- Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION OF REQUIREMENT: The National Institutes of Health, National Institutes on Aging, Laboratory of Behavioral Neuroscience intends to procure on a sole source basis a service project that will use a method called quantitative targeted metabolomics for measuring the absolute concentrations of 180 metabolites in serum and post-mortem brain samples to discover predictive blood biomarkers of Alzheimer's disease (AD) and markers of resilience to AD pathology. This method is a novel approach distinct from traditional and most widely used metabolomics methodology where only relative quantification of metabolites can be determined between different samples. Relative quantification provides limited information as it only allows comparative differences (i.e. lower or higher) between samples to be determined. In order to meet the goal of the proposed study i.e. the discovery of metabolites that can predict the onset of AD before clinical symptoms, accurate and absolute quantification of metabolites is a critical requirement. This is also the ultimate goal of the proposed biomarker study i.e. the development of a blood-test for the prediction of AD that could one day be used in clinical practice settings. This can only be accomplished by the accurate estimation of absolute metabolite concentrations in serum samples. Background: There is currently a pressing need to identify predictive blood-based biomarkers of Alzheimer's disease (AD). With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, the emerging paradigm shift in Alzheimer's research calls for disease-modifying treatments to be initiated in older individuals who are in preclinical stages of disease i.e. prior to the onset of overt cognitive decline1. Currently the only modalities that are available for this purpose are assays of cerebrospinal fluid (CSF) markers of Aβ42 and tau (total and phosphorylated) and neuroimaging methods that quantify brain atrophy or fibrillar amyloid deposition. Therefore, the focus is on blood-based biomarkers of AD that accurately reflect well-established endophenotypes of AD pathology such as brain atrophy and in vivo fibrillar Aβ deposition4-8. Using mass spectrometry-based proteomic analyses in combination with multi-modal neuroimaging, these studies have revealed a robust peripheral signal from the plasma proteome that appears to be associated with AD pathology. Purpose and Objectives: The purpose of this acquisition is to award a service agreement for the quantitative targeted metabolomics for measuring the absolute concentrations of 180 metabolites in serum and post-mortem brain samples to discover predictive blood biomarkers of Alzheimer's disease (AD) and markers of resilience to AD pathology, according to the specific requirements outlined in the Statement of Work (SOW). Period of Performance: September 30, 2015 - September 29, 2016 Project Requirements: The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in the Statement of Work. The tasks include performing a quantitative targeted metabolomics assays on human serum samples from non-demented older individuals and converters to AD non-demented older individuals in the Age Gene/Environment Susceptibility-Reykjavik Study, and cerebrospinal fluid (CSF) from participants in the BIOCARD study, to measure and assay the concentrations of small metabolites. Finally, the Contractor shall perform statistical analysis to identify small metabolite markers in serum and CSF that predict incident AD and return all unused specimen to their place of origin. Please refer to the attached Statement of Work for complete details and specifications for Contractor Requirements/Tasks, Deliverables, Government Responsibilities and Reporting Requirements. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION: The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the sources sought notice published in the FedBizOpps on February 23, 2015, synopsis number HHS-NIH-NIDA-SSSA-SS-2015-152, entitled Predictive Blood and Cerebrospinal Fluid Metabolomic Markers in Alzheimer's Disease. Due to the use of a method called quantitative targeted metabolomics for measuring the absolute concentrations of 464 metabolites in serum samples to discover predictive blood biomarkers of Alzheimer's Disease (AD), which is a method that is a novel approach distinct from traditional and most widely used metabolomics methodology, where only relative quantification of metabolites can be determined between different samples. Relative quantification provides limited information as it only allows comparative differences between samples to be determined. In order to meet the goals of the proposed study, accurate and absolute quantification of bio metabolites on a large scale is necessary. There are no other sources besides the proposed Contractor that can service the project using absolute quantification on a large scale. BIOCRATES Life Sciences AG is the intended source for this award. CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All questions must be received by April 8, 2015 at 12:00PM and must reference number HHS-NIH-NIDA-PSOL-15-188. Responses may be submitted electronically to Samantha Kelly at Samantha.Kelly2@nih.gov. All responses must be received by April 16, 2015 at 12:00PM and must reference number HHS-NIH-NIDA-PSOL-15-188. Responses may be submitted electronically to Samantha Kelly at Samantha.Kelly2@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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